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| |  ICML: Dose-Escalated CHOP Therapy plus Etoposide Effective against Aggressive Non-Hodgkin’s Lymphoma By Claudia Orellana LUGANO, SWITZERLAND -- June 19, 2002 -- Mega-CHOEP, a high-dose sequential CHOP regimen (cyclophosphamide, adriamycin, vincristine, and prednisone) plus etoposide, is a feasible primary treatment for aggressive non-Hodgkin’s lymphoma. A phase II study indicates the therapy, which requires stem cell transplantation when completed, has a low toxicity profile and an encouraging survival rate. The study was carried out by researchers from hospitals in various German cities, on behalf of the German High-Grade Non-Hodgkin’s Lymphoma Study Group. Dr. Bertham Glass, from University Hospital in Göttingen, Germany, presented the findings here Friday at the 8th International Conference on Malignant Lymphoma (ICML). From February 1997 to January 2002, the study enrolled 253 patients with newly diagnosed aggressive non-Hodgkin’s lymphoma. All patients, aged 18 to 60 years, had a high risk of relapse, defined by elevated lactate dehydrogenase (LDH) levels. Treatment was given in two dose levels: · 47 patients assigned to dose level 1 received cyclophosphamide 1,500 mg/m², adriamycin 70 mg/m², vincristine 2 mg/m², etoposide 450 mg/m², and prednisone 500 mg/m² in the first cycle. In the second and third cycles cyclophosphamide was increased to 4,500 mg/m² and etoposide to 600 mg/m². In the fourth cycle cyclophosphamide was further increased to 6,000 mg/m² and etoposide to 1,000 mg/m². Because dose-limiting toxicity was not reached at dose level 2, a third dose level with further escalated etoposide is being given to the remaining 129 patients in further studies, the data for which are not yet available. In 109 of 110 evaluable patients, sufficient peripheral blood progenitor cells could be harvested for all scheduled cycles of stem cell transplantation. Recovery of leukocytes was achieved after 12, 14, 15, and 16 days and recovery of platelets at days 14, 16, 17, and 20 after courses 1-4 of Mega-CHOEP. There were four treatment-related deaths (3.6 percent). "We started this trial in search of an optimal high-dose therapy protocol for primary treatment of aggressive non-Hodgkin’s lymphoma, and we ended up with a treatment-related mortality of less than 4 percent," said Dr. Glass. After two years, overall survival was 75 percent and freedom from treatment failure was 67 percent. Only one relapse occurred after more than two years. Dr. Glass thinks the results are encouraging. "Since the strategy seems to be effective in a phase II study with, to my view, a fairly high number of patients, we will certainly continue," he said. "This study is now the basis of an upcoming phase III study in our group."
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